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EPIRUBICIN HYDROCHLORIDE INJECTION DIN 02409372

Status: Approved
Holder: OMEGA LABORATORIES LIMITED
Molecule: EPIRUBICIN HYDROCHLORIDE

Health Canada record

Active ingredient(s)EPIRUBICIN HYDROCHLORIDE 2 MG
Dosage formSolution
RouteIntravenous
SchedulePRESCRIPTION
ClassHuman
ATCL01DB03 EPIRUBICIN
Original market date
Current status date23-Jul-2013
SourceHealth Canada DPD

Establishment licence of the holder

Omega Laboratories Ltd. (now Juno Pharma Canada Inc.) — licence 100277, not currently licensed, last inspection rating C (2025-05-20).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing EPIRUBICIN HYDROCHLORIDE

DINProductCompanyFormStrengthStatus
02413221EPIRUBICIN HYDROCHLORIDE INJECTIONSTRIDES PHARMA CANADA INCSolutionEPIRUBICIN HYDROCHLORIDE 2 MGApproved
02324091EPIRUBICIN HYDROCHLORIDE INJECTIONTEVA CANADA LIMITEDSolutionEPIRUBICIN HYDROCHLORIDE 2 MGMarketed
02322242EPIRUBICIN HYDROCHLORIDE INJECTIONUMAN PHARMA INCSolutionEPIRUBICIN HYDROCHLORIDE 2 MGApproved
02301067EPIRUBICIN HYDROCHLORIDE FOR INJECTIONHOSPIRA HEALTHCARE ULCPowder For SolutionEPIRUBICIN HYDROCHLORIDE 50 MGCancelled Post Market
02312093EPIRUBICIN HYDROCHLORIDE INJECTIONFRESENIUS KABI CANADA LTDSolutionEPIRUBICIN HYDROCHLORIDE 2.0 MGDormant
02264927EPIRUBICIN HYDROCHLORIDE INJECTIONPFIZER CANADA ULCSolutionEPIRUBICIN HYDROCHLORIDE 2 MGCancelled Post Market
02303892EPIRUBICIN HYDROCHLORIDE INJECTIONACCORD HEALTHCARE INCSolutionEPIRUBICIN HYDROCHLORIDE 2 MGCancelled Post Market
02323001EPIRUBICIN HYDROCHLORIDE INJECTIONPHARMACEUTICAL PARTNERS OF CANADA INCSolutionEPIRUBICIN HYDROCHLORIDE 2 MGCancelled Pre Market
02387379EPIRUBICIN HYDROCHLORIDE INJECTIONSANDOZ CANADA INCORPORATEDSolutionEPIRUBICIN HYDROCHLORIDE 2 MGCancelled Pre Market
02065703PHARMORUBICIN PFSPHARMASCIENCE INCSolutionEPIRUBICIN HYDROCHLORIDE 2 MGCancelled Post Market
02065746PHARMORUBICIN RDFPFIZER CANADA ULCPowder For SolutionEPIRUBICIN HYDROCHLORIDE 10 MGCancelled Post Market
02069512PHARMORUBICIN RDFPFIZER CANADA ULCPowder For SolutionEPIRUBICIN HYDROCHLORIDE 50 MGCancelled Post Market
00640069PHARMORUBICIN RDF INJ 50MG/VIALADRIA LABORATORIES OF CANADA LTD.Powder For SolutionEPIRUBICIN HYDROCHLORIDE 50 MGCancelled Post Market
02410400PMS-EPIRUBICINPHARMASCIENCE INCSolutionEPIRUBICIN HYDROCHLORIDE 2 MGCancelled Post Market

Notices of Compliance

NOCDateSubmissionReason
145832013-07-23Abbreviated New Drug Submission (ANDS)

International API supply for EPIRUBICIN HYDROCHLORIDE

7 valid EDQM Certificates of Suitability from 7 holders. 7 active FDA Drug Master Files.

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